Study of Hepatic Responses in Patients Receiving Direct-acting Anti-HCV Drugs

Completed

• Conditions: Hepatitis C
• Interventions: Procedure: Liver Biopsy

• Registration Number: NCT02532907
• Lead Sponsor: University of Colorado, Denver

Brief Summary

This study is designed to obtain and store samples of serum and liver tissue in HCV (HepC Virus)-infected patients being treated with direct-acting antiviral (DAA) therapy, and to determine the effect of new DAA therapies on HCV-related responses in the liver and peripheral blood.

The introduction of new DAAs regimens that do not include IFN provides unique and novel opportunities to examine whether successful treatment-induced eradication of viral antigen results in reconstitution of T cell immunity. serum and liver tissue samples will be collected and stored in hopes of improving treatment and outcomes for future patients.

Detailed Description

This study is designed to obtain and store samples of serum and liver tissue in HCV-infected patients being treated with DAA therapy.

A liver biopsy will be performed pre-treatment for research reasons. A small liver sample that is not required for pathologic analysis will also be stored. Patients will undergo another liver biopsy at either 4 or 12 weeks after initiation of DAA therapy.

Any patients with HCV-related liver disease (age \> 18) will be considered for this study.

Patients will have a 120 ml blood draw for research purposes at baseline and 12 weeks after stopping DAA treatment along with a 60 ml blood draw at 2, 4, 8, and 12 weeks of treatment.

The liver biopsy at baseline and then either at 4 or 12 weeks will be examined using molecular techniques to measure transcription of key genes involved in the antiviral response.

Study Timeline

• Study Start: 2015-08
• Study First Submitted: 2015-08-13
• Study First Submitted QC: 2015-08-21
• Study First Posted: 2015-08-26
• Primary Completion: 2018-07-10
• Study Completion: 2018-07-10
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-17
• Last Update Posted: 2018-09-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients who will have their second Liver biopsy at week 4	Liver Biopsy	The 4 week time point is performed in lieu of the 12 week and the purpose of this time point is to evaluate earlier responses and transcriptional changes that might predict viral clearance or treatment failure in a subset of patients.
Patients who will have their second Liver biopsy at week 12	Liver Biopsy	Liver biopsies will be obtained at week 12 when most DAA treatments end in order to compare the hepatic responses induced or reduced by clearance of HCV

Primary Outcome Measures

Name	Time	Method
Changes in gene array from baseline to either 4 or 12 weeks after treatment.	1 year	To examine the effect of new DAA therapies on HCV-related responses in the liver and peripheral blood.

Trial Locations

Locations (1)

Sandra Boimbo; 🇺🇸 Aurora, Colorado, United States